Pigmented Tumours of the Anterior Ocular System in ChildrenNCT07120178
Imaging and Evolution of Pigmented Tumors of the Anterior Ocular System in Children
An observational study of Pigmented Tumours of the Anterior Ocular System in Children, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The investigators were interested in pigmented tumours of the anterior segment of the eye in children because there is very little data on their evolution. The nevus is the most common conjunctival tumour. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pigmented Tumours of the Anterior Ocular System in Children
- What is being tested?
- slit lamp examination, dermatoscopy examination x20 and x400 and confocal microscopy examination
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with pigmented tumors of the anterior ocular system
Who may be able to join
- Patient who had a first dermato-ophthalmological consultation < 18 years old with pigmented tumors of the anterior ocular system
Who cannot join
- patient over 18 years old at first examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne
Jean Luc PERROT, Md, PhD, (0)477828508 ext. +33, j.luc.perrot@chu-st-etienne.fr
About this study
The investigators were interested in pigmented tumours of the anterior segment of the eye in children because there is very little data on their evolution. The nevus is the most common conjunctival tumour.
The challenge is to be able to adapt the child's follow-up according to the imaging and avoid an invasive procedure such as surgical excision if the imaging does not find any suspicious cells despite a change in size or colour. This would also make it possible to answer parents' questions about the potential evolution of the tumour. Finally, it would enable the frequency of monitoring to be personalised according to the data analysed. The tests are all non-invasive and painless.
- Being tested
- slit lamp examination, dermatoscopy examination x20 and x400, confocal microscopy examination
- Keywords
- pigmented tumours of the anterior ocular system in children, CONJUNCTIVAL TUMORS CHILDREN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slit lamp examinationOther
data collected: tumor size, pigmentation, vascularization, cells
dermatoscopy examination x20 and x400Other
data collected: tumor size, pigmentation, vascularization, cells
confocal microscopy examinationOther
data collected: tumor size, pigmentation, vascularization, cells
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Children with pigmented tumors of the anterior ocular system Receives: Other: slit lamp examination; Other: dermatoscopy examination x20 and x400; Other: confocal microscopy examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The size and pigmentation of the tumor
Measurement of the size of the tumor with dermatoscopy x20 in mm and pigmentation with the slit lamp as well as dermatoscopy x20 and x400
Measured: Day 1
Secondary outcomes (2)
Describe the evolution according to age
Data collected from medical records
Measured: Day 1
Describe the evolution according to sex
Data collected from medical records
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Apr 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmented Tumours of the Anterior Ocular System in ChildrenStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Luc PERROT, Md, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120178
- Sponsor's protocol ID
- IRBN222025/CHUSTE
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and Evolution of Pigmented Tumors of the Anterior Ocular System in Children
- ClinicalTrials.gov ID
- NCT07120178
- Acronym / sponsor ID
- IRBN222025/CHUSTE
- Keywords
- pigmented tumours of the anterior ocular system in children, CONJUNCTIVAL TUMORS CHILDREN
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators were interested in pigmented tumours of the anterior segment of the eye in children because there is very little data on their evolution. The nevus is the most common conjunctival tumour.
The challenge is to be able to adapt the child's follow-up according to the imaging and avoid an invasive procedure such as surgical excision if the imaging does not find any suspicious cells despite a change in size or colour. This would also make it possible to answer parents' questions about the potential evolution of the tumour. Finally, it would enable the frequency of monitoring to be personalised according to the data analysed. The tests are all non-invasive and painless.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: slit lamp examination, Other: dermatoscopy examination x20 and x400, Other: confocal microscopy examinationChildren with pigmented tumors of the anterior ocular system |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with pigmented tumors of the anterior ocular system
Key inclusion criteria (1 listed)
- Patient who had a first dermato-ophthalmological consultation < 18 years old with pigmented tumors of the anterior ocular system
Key exclusion criteria (1 listed)
- patient over 18 years old at first examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| slit lamp examinationdata collected: tumor size, pigmentation, vascularization, cells | Other | Observational group |
| dermatoscopy examination x20 and x400data collected: tumor size, pigmentation, vascularization, cells | Other | Observational group |
| confocal microscopy examinationdata collected: tumor size, pigmentation, vascularization, cells | Other | Observational group |
Primary outcome
The size and pigmentation of the tumor
Time frame: Day 1
Measurement of the size of the tumor with dermatoscopy x20 in mm and pigmentation with the slit lamp as well as dermatoscopy x20 and x400
2 secondary outcomes
Describe the evolution according to age
Time frame: Day 1
Describe the evolution according to sex
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Luc PERROT, Md, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigmented Tumours of the Anterior Ocular System in Children, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Luc PERROT, Md, PhD ((0)477828508 ext. +33, j.luc.perrot@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The size and pigmentation of the tumor (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.